Archive for August, 2009

Vermont Governor Jim Douglas’ action to greatly reduce the staffing at the Middlebury office has had a significant impact on the ability of the office to support public health in the Addison County. While a leaner office might have been an economic reality given the state’s fiscal problems, the draconian cuts made have threatened its primary roles of managing the WIC caseload and acting as a liaison between the health department, primary care offices and the schools. With the poor economy creating an increased demand for health and human services, the timing of these staff cuts could not be worse. In the 2005-7 U.S Census Data 11% of all Vermonters and 16% of children were food insecure (unable to access adequate food for their needs at all times) and those numbers are likely to worsen in 2009. The community liaison for the health department must now spend the bulk of her time supporting the WIC program and the public health nurse is trying his best to cover all of the other local programs and services.

The Vermont Department of Health is caught between the governor’s mandate and its public health mission. In order to preserve its core central functions the health department has tried to spread out the cuts as broadly as possible. Aligned against the cuts are the primary care physicians, the school nurses, the town health officers and various advocacy groups such as The Vermont Campaign to End Childhood Hunger. The local physicians and town health officers feel that the remaining public health nurse is too stretched to be able to provide as much support. The school nurses have essentially lost the services of the community liaison and the health department nutritionist is unable to provide the intended support to the schools due to the demands of WIC in the face of the staffing cuts. Since WIC only covers children 0-5 years of age, the advocacy and community groups are frustrated in their ability to combat hunger in the schools as the local health department office is now unable to provide meaningful support for school age children.

It is important that the governor hear from as many citizens as possible that the cuts in health services threatens the integrity of the social safety net just when it is most needed. Please contact the governor and your local legislators to register your concerns and urge them to reinstate enough health department workers to provide for adequate public health support in Addison County.

The current Health Reform debate in the United States has been loud, confusing and sometimes combative. From fears of socialized medicine, escalating federal budget deficit to nearly 50 million uninsured Americans, one thing is certain – the current state of our health care system is unsustainable. While several facets of the system have been discussed, one topic is surprisingly absent – Medical tort reform.

About 10% of medical costs are attributed to medical malpractice lawsuits. While some argue that it is a negligible amount, the impact is undeniable. Physicians respond to medical malpractice lawsuits in two ways. Firstly, they purchase malpractice insurance to protect against lawsuits. Secondly but more insidiously, they practice “defensive medicine”. Defensive medicine includes ordering extra, sometimes needless diagnostic tests, procedures and referrals for protection.

A 2008 survey in Massachussetts revealed that 83% of physicians practice defensive medicine. It has been estimated that over $200billion a year is spent on defensive medicine. The epidemic of frivolous lawsuits by the trial lawyers is also having a tremendous impact on the cost of malpractice insurance premiums especially in specialties such as Ob/Gyn and orthopedic surgery. The cost of medical torts is up from $15.5billion to $30.4billion from 1997 to 2007.

Why the silence?

The Republicans called for medical tort reform in the past. The trial lawyer constituent is a large one for the Democratic Party. Some wonder if this is why the Democrats are silent. On the other hand, some argue that it is not a large enough drain on the health system. Patients are also concerned about the freedom to sue for medical negligence.

However, health care should be a non-partisan issue. While the monetary costs might not be as high as the other facets, one could argue that the impact on the practice of medicine is immense and disastrous. With more physicians leaving medicine for the inability to pay high malpractice premiums, an increasing strain on the patient-physician relationship due to defensive medicine and the predatory nature of the “ambulance-chasers”, medical tort reform needs to be addressed.

What to do?

Some reform advocates are calling for caps on malpractice settlements. Others are calling for a complete dismantling of the medical tort system, the elimination of trial lawyers and for health insurance taxes to pay for the consequences of medical negligence. Either way, medical tort reform should be explored as a means of cutting health care costs, improving efficiency and ultimately, improving patient care. It is time for medical tort reform. The silence must be broken.

India like any other commonwealth country which has risen out of a long drawn imperial abuse is deeply ridden by poverty, which for most westerners is unimaginable. But that’s not what this country is famous for these days. In today’s neoliberal world India is synonymous with the word outsourcing. Its english speaking highly educated human resource has been harnessed to bring about a radical change in how businesses are run these days. May it be the textile industry, diamond cutting, information technology or technical and management consulting. Pharmacuticals clinical trials too are now outsourced to India and this industry is estimated to be worth $2 billion by 2010. India ranks number one country for clinical trials.

This situation begs to ask the question is “Why India has suddenly become a lucrative hot spot for Western Biopharmaceutical Companies to conduct their clinical trials?”

Here are a few pointers;

Indian government is doing all it can to make India a hot spot of clinical trials.

The amendments made in the Drug Patency Act which was passed in 2005 made the indian legal environment congenial for pharmaceutical companies to conduct their research in India by protecting their research data collected in India on their newer drugs from local completive India pharmaceutical companies. This protect their intellectual property and protect them from cheap local knockoffs to be produced in India.

The government has also decreased the limits for the time taken for drug trial applications to be cleared – 90 days for phase 1 trials, 45 days for phase 2 trials and 45 days for phase 3 trials. If the DCGI( Drug Control ler General of India) does not reply within the given period, the application is taken to have been approved.

Schedule Y of the Drugs and Cosmetics Act permits also has the ‘same phase’ drug trials in India as in other countries and also permits phase 1 trials of foreign drugs. Till then, the law required that any foreign drug tested in India should be tested at a phase ‘behind’ what was already done elsewhere – the three phases for human trials being: phase 1 for safety to be tested on healthy volunteers, phase 2 for safety and efficacy and phase 3 a much larger sample for efficacy. (These tests must be preceded by laboratory tests suggesting the drug works and in toxicology test on animals for the drug’s safety.)

Though the Drug Controller General of India Ashwini Kumar is quoted saying that the government has started training drug inspectors to audit trials, lapses in regulations have surfaced time and again. The latest uproar was about the Death of 49 infants at one of the prestigious AIMS institute. The London based biopharma company Shire is researching on a drug for Gaucher’s disease and the trial population has to be between 1 to 2 yrs of age. About 1500 children had been a part of this trial and there was a sudden death of 49 infants. The said drug is currently in front of the US FDA for approval. Instances like these have raised question about the ethical ground s of conducting research in countries like India. (http://www.timesonline.co.uk/tol/news/world/asia/article4568717.ece )

According to IGATE Clinical Research the “Indian Advantage” for clinical trial is :large numbers of people with a range of illnesses, relatively low costs, availability of trained humanpower and infrastructure, high enrollment rates (higher than in the West), good patient compliance/ retention, and an “increasingly accommodating regulatory environment” (http://www.igatecorp.
com/icri/html/aboutus/tia.htm) is responsible for the explosion of drug trials in India. IGATE also mentions that India has people with the right diseases. They’re also ‘treatment naïve’ – they will not have been able to afford treatment – so they are ideal for testing new drugs.

These trials done in India have cut the cost of clinical trials by 60% and the trials can be conducted at a record pace.

Things sound too good to be fair

The Helsinki Declaration on ethical guidelines for biomedical research on humans, and the ICMR’s guidelines on the same subject, state unequivocally that drugs must be tested against the best proven treatment and it is unethical to use a placebo (sugar pill) if an effective treatment exist. But there have been in instances in which these rules have been bent. In case of a trial done by a US based company for Bipolar disorder the patients in the clinical trial where kept off the standard drug for bipolar disorder prior to starting the trial to cleanse there system of the drug and prevent any biases.

In case of the drug trial for Bipolar medication Risperdal : One was given the experimental treatment Risperdal, the other group were given a placebo. This effectively leaves some patients without any form of treatment during the trial which is essentially unethical.

In case of a anticancer drug the patients were never told of the standard treatment for that(pancreatic cancer) and where offered only the drug on trial.(M4N)

What is our concern?

The current environment for clinical trials raises five main ethical issues:

Patient recruitment onto drug trials

Informed consents

The trust between a doctor and their patient

The methodology implemented during a drug trial

The cost and accessibility of drugs in the developing world

The human rights groups are asking three basic changes in this existing structure:

Do clinical trials for conditions or diseases prevalent in that subpopulation a

Make those drugs available to the patients included in the trial at subsidized rate after the trial was successful and the drug approved

However, drinking and driving still remains a problem. The next steps must also involve the medical community. The term “teachable moment” has often been used to characterize ED visits, where sudden adverse health effects provide a window of opportunity to motivate individuals to change; emergency personnel therefore play a key role in promoting health behavior change. In the United States and in England, motivational interviewing by ED personnel has consistently led to a decrease in alcohol-related injuries and traffic violations.

Unfortunately, ED counseling in Canada is rare. EDs are fast-paced and busy, and lack of funding and personnel resources have limited the implementation of these programs. There is therefore an urgent need for increased funding and hiring of ED dedicated counselors to capitalize on the ED “teachable moment”. Within this window of opportunity, motivational interviews should be performed on all consenting ED patients with alcohol dependency or abuse problems.

As Washington comes closer to reforming the nation’s health care system, many may wonder whether or not Congress will take on another important, but contentious, policy issue: medical malpractice.

Last month, the Congressional Budget Office (CBO) released a scorecard for the lead health reform proposals in Congress. To the dismay of some, the critical report showed nominal savings from the proposed reforms and no change to long-term health care costs[i].

Advocates of medical malpractice reform, such as physician and hospital associations, often argue that current tort law needs adjustment to preclude costly and inefficient health care claims. Those same advocates believe that reform would ultimately lead to less defensive medicine and an overall reduction in the nation’s health care costs. In fact, the Pacific Research Institute agrees, recently estimating that that defensive medicine wastes more than $200 billion a year.
Opponents of medical malpractice reform, such as the plaintiff attorneys and the patient safety organizations, have argued that there is a nominal relationship between health care costs and medical malpractice suits.

The dynamics around this issue involve the aforementioned health care stakeholders who also happen to be key participants in the overall health reform negotiations. Consequently, the tug of rope on this issue may ultimately result in the passage of a health reform package that does not address medical malpractice. However, claims of potential savings may force the political powers to look more closely at the issue if they are forced to offset health care costs over time.

Tobacco use, both through cigarette smoking and the use of a local water pipes called shishas, is a major public health problem in Jordan. Usage rates are extremely high among both youth 13-15 (13.6%), and adults (29%), and the impact is felt even on the nation’s infant population. The health problems associated with both cigarette smoking and the use of a shisha are well documented.

According to the WHO’s recent study on global tobacco use (page 192), Jordan has the highest adult smoking prevalence in the Eastern Mediterranean region, and while advertising bans are considered both comprehensive and well enforced, smoke-free policies are very limited and weakly enforced. Taxes are also high at 39% of the total cost, but despite the expense this health behavior is still widely practiced.

A quick glance at a few responses to the recent Public Health Law reveals that the problem is not just one of enforcement, but that most of the public is either under informed or unconvinced about the danger of smoking. The only issue that comes up is about the logistics of separating smokers and non-smokers, rather than the tobacco-related health crisis. In fact, a recent study showed that even health professionalsin Jordan are given neither education about the addictive qualities of nicotine, nor training in how to educate their patients about smoking cessation.

A major change in policy must occur. For too long, the efforts in Jordan have revolved around restricting the locations of tobacco use or taxing its purchase, but the greater battle to win the hearts and minds of the population through healthcare provider education, teaching young children through school-based health education programs, and mass media campaigns must be implemented if there is to be hope of lasting change in the prevalence of tobacco consumption in Jordan.

The American Cancer Society estimates that 11,270 women will be diagnosed with cervical cancer this year in the U.S.; 4,070 will die from it. Cervical cancer is caused primarily by the Human Papillomavirus (HPV), which is the most common sexually transmitted disease. Wisconsin parents have the opportunity to greatly decrease their daughter’s risk of cervical cancer by providing them with the HPV vaccine, Gardasil.

The Advisory Committee on Immunization Practices (ACIP) recommends that 11- to 12-year-old females receive the vaccine, with catch-up for females aged 13 through 26 years. When given prior to sexual debut, Gardasil can prevent up to 70% of cervical cancer cases. Parents, however, have concerns about the vaccine’s safety and its effect on children’s sexual activity. But as of June 1, 2009, the CDC reports that more than 25 million doses of Gardasil were distributed in the United States with little or no significant adverse effects. The serious side effects noted have not been proven to be related to the vaccine. In addition, scientific evidence does not support the idea that a vaccine can promote sexual activity.

To help parents separate HPV fact from fiction, Wisconsin Senator Lena Taylor proposed Wisconsin Senate Bill 252 on August 16, 2007. This bill would have directed the Department of Public Instruction (DPI), with the Department of Health and Family services (DHFS), to make educational materials about human papillomavirus and Gardasil available to parents and guardians of pupils enrolled in grades 6 to 12 through the school district. On March 21, 2008, Senate Bill 252 failed following a firestorm of misinformation from HPV vaccine opponents.

Help put bill 252 back on the table. Wisconsin parents have a right to the best information available to protect their daughters from cervical cancer.

The CDC Swine Flu vaccine rationing scheme published in a press release on July 29, 2009 for the predicted fall-winter 2009-2010 season eliminates those 65 and older from the equation. CDC Newsroom Press Release July 29, 2009 The problem is that this age group utilizes more healthcare dollars during influenza season than any other age group and is 10 times more likely to die of respiratory and cardiac complications of influenza than those 50-64. Prevention and Control of Seasonal Influenza with Vaccines This rationing has angered our senior citizens and the AARP and seems to support their idea that government bureaucrats are rationing healthcare away from the aging population.

Pharmaceutical companies are quickly producing and studying this new H1N1 Swine Flu vaccine, but there won’t be enough for everyone. National infectious disease groups and public health advocacy groups support vaccine rationing and there are many reasons to justify this allocation.

1. Data from case reports of those severely affected by this past spring/summer H1N1 pandemic suggests those under 60 required more life saving intensive care measures, higher hospitalization rates and had higher mortality rates than those over 60. CDC Novel H1N1 Flu | Facts and Figures

2. Currently the three individuals who either died or required extreme life saving measures at my hospital were ages 20-24.

3. The economic burden of influenza in the US, including loss of productivity, is 87 billiondollars. This includes 10 billion in healthcare dollars. A swine flu epidemic this winter would cost the US even more with a younger age group severly affected. Loss of wages in this group would also affect the tax base which is an important issue in this period of national economic crisis (the bail out of Wall Street) and the revamping healthcare.

Therefore, despite these guidelines being in oppososition to recommendations from past seasonal influenza experience, the evidence is there to support and justify this rationing.

Buprenorphine is the only available medication approved in the United States that can be prescribed from a doctor’s office to treat opioid addiction. Under the Drug Addiction Treatment Act of 2000, an amendment to the Controlled Substances Act, passed by the U.S. Congress, doctors who complete an 8 hour training course can be certified by the Drug Enforcement Agency to prescribe buprenorphine.

The certification is limited, however, to medical providers who have a MD and shuts out midlevel practitioners, who are more likely to choose to treat opioid-addicted individuals, from joining in the fight against this chronic and relenting disease of opioid addiction. Midlevel practitioners such as nurse practitioners and physician assistants are allowed to prescribe opioid narcotic medications yet are restricted from prescribing the much less harmful buprenorphine!

The only other option for opioid substitution therapy is methadone and methadone is only available from a limited number of methadone clinics which treat about 15% of all those people who desperately need medical treatment. Over a million people continue to need treatment for their opioid dependency and not enough physicians are stepping up to the plate to take on this burdening challenge!

Given that buprenorphine is effective and safe with very low risk of overdose and a much milder withdrawal process than methadone and given the huge need for providers to take on this challenge of treating the opioid addicted population, we all need to petition our congressmen and women to expand the law, allowing midlevel practitioners to prescribe buprenorphine to treat this chronic medical condition that impacts every level of our society.

To listen to one mother’s experience, please click here. The 1 minute video you will see is from the National Alliance of Advocates for Buprenorphine Treatment website.